Assurans Injection 12.5ml
Key Information
Generic Name
Generic Name Sildenafil 0.8 mg
Manufacturer
Cipla Ltd
Country of Origin
India
Detailed Information
Introduction
INTRODUCTIONASSURANS contains Sildenafil which belongs to the group of medicines called Phosphodiesterase type 5 (PDE 5) inhibitors. It is used in adults to manage pulmonary arterial hypertension (PAH). PAH can be defined as an increased blood pressure in the blood vessels that supplies the lungs. It can be caused due to narrowing of blood vessels (arteries) supplying the heart and the lungs. Symptoms of PAH might include shortness of breath, tiredness, weakness, and feeling faint. Sildenafil reduces blood pressure within the lungs by relaxing the blood vessels supplying the lungs. This enhances blood flow and oxygen supply to the lungs which ultimately reduces pressure within the lungs and improves its functions. ASSURANS should be used in patients who temporarily cannot take any medicines orally to manage pulmonary arterial hypertension. Before receiving ASSURANS inform your doctor if you have any liver, kidney, or heart problems. It should be used with caution in patients with eye problems, stomach problems, anemia, or penile deformity. Avoid consuming grapefruit juice just before receiving ASSURANS, as it may increase the risk of
Uses
OF ASSURANS Manages pulmonary arterial hypertension in adults
How It Works
ASSURANS reduces blood pressure within the lungs, where sildenafil acts by blocking the effects of certain enzymes (PDE5) which limits blood flow to the lungs. As a result, it causes widening of blood vessels (arteries) supplying the lungs, improves blood supply to the lungs and enhances pulmonary functions.
Directions for Use
ASSURANS will be given to you only by a doctor or a nurse into the vein (intravenously). Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition.
Side Effects
childbearing potential should use suitable contraceptive method to avoid pregnancy while undergoing therapy with ASSURANS. It is also not recommended for use in children and adolescents (below 18 years). The most common side effects of ASSURANS are headache, muscle pain or stiffness, dizziness, blurred vision, or flushing. Consult your doctor if any of the side effect troubles you. Also inform your doctor if you experience any painful or prolonged erections after receiving ASSURANS. USES OF ASSURANS Manages pulmonary arterial hypertension in adults HOW ASSURANS WORKSASSURANS reduces blood pressure within the lungs, where sildenafil acts by blocking the effects of certain enzymes (PDE5) which limits blood flow to the lungs. As a result, it causes widening of blood vessels (arteries) supplying the lungs, improves blood supply to the lungs and enhances pulmonary functions. DIRECTIONS FOR USEASSURANS will be given to you only by a doctor or a nurse into the vein (intravenously). Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition. SIDE EFFECTS OF ASSURANSCOMMON flushing, fever headache, shaking and migraine effects on nose (nosebleed, stuffy nose, runny nose and inflammation of sinuses) effects on vision (includes light sensitivity, blurred vision, color tinge to vision, visual disturbance, eye irritation, red eyes) nausea low blood pressure pain in legs, arms, back and muscles night sweats infection under skin and redness decreased number of RBCs flu-like symptoms anxiety difficulty in sleeping retention of fluid reduced sense of touch or pricking of pins and needles sensation vertigo (spinning sensation) dry mouth digestive system issues (stomach pain, outward swelling of the stomach, indigestion, heartburn and piles) cough diarrhea UNCOMMON eye problems (reduced sharpness of vision, double vision and abnormal sensation in the eye) breast enlargement in men presence of blood in semen/ urine penile bleeding RAREConsult your doctor immediately if you experience any of the following side effects after receiving ASSURANS: prolonged or painful erection decreased or loss of vision in one or both eyes
Warnings & Precautions
& PRECAUTIONSPREGNANCYASSURANS is generally not recommended for use in pregnant unless considered necessary by the physician. Therefore, consult your doctor before receiving it. Women of child-bearing potential should use proper contraceptive method to avoid pregnancy while undergoing therapy with ASSURANS. BREASTFEEDINGASSURANS should be used with caution for use in breastfeeding women. Therefore, consult your doctor before receiving it. DRIVING AND USING MACHINESDo not drive or operate any machines if you experience dizziness or blurred vision after receiving ASSURANS. ALCOHOLAvoid consumption of alcohol while receiving ASSURANS as it may reduce the effectiveness of ASSURANS. KIDNEYASSURANS should be used with caution in patients with kidney problems. Therefore, consult your doctor before receiving it. LIVERASSURANS is not recommended for use in patients with severe liver diseases. It should be used with caution in patients with other minor liver problems. Therefore, consult your doctor before receiving it. ALLERGYDo not receive ASSURANS if you are allergic to Sildenafil. LUNGSASSURANS should be used with caution in patients with pulmonary hypertension caused due to narrowing or blockade of veins (instead of arteries). Consult your doctor before receiving it. HEART DISEASEASSURANS is not recommended for use in patients with severe heart diseases (such as any recent heart attack or stroke, or severe low blood pressure). It should be used with caution in patients with other heart problems (such as problems in heart chambers or valves, low blood pressure at rest). Therefore, consult your doctor before receiving it. OTHERSASSURANS is not recommended for use if you: previously had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION; a type of nerve damage caused due to lack of blood and oxygen supply to the eye) Before receiving ASSURANS inform your doctor if you: have sickle cell anaemia (an inherited blood disorder characterized by low RBC count) have any type of rare inherited eye diseases (such as retinitis pigmentosa) have cancers of blood (leukaemia) or bone marrow (multiple myeloma) have penile deformation have Peyronie’s disease (development of fibrous scar tissue that results in painful erection) have stomach ulcer or bleeding disorder such as haemophilia have nosebleeds have dehydration due to diarrhoea, fever, or less intake of fluids or increased sweating Use in pediatrics: ASSURANS is not recommended for children and adolescents (under the age of 18 years). Therefore, consult your doctor before receiving. Use in geriatrics: ASSURANS should be used with caution in elderly patients. Therefore, consult your doctor before receiving.
Drug Interactions
SA. Drug-Drug interactions: Before receiving ASSURANS, inform your doctor if you are taking any of the following: nitrates or amyl nitrites (used for reliving chest pains) Ex. nitroglycerin and isosorbide dinitrite other medicines used to manage PAH (Ex. riociguat, bosentan or iloprost) medicines used to manage prostate problems or blood pressure such as alpha-blocker (Ex. silodosin, doxazosin) ketoconazole or itraconazole (used to manage fungal infections) St. John’s wort or nefazodone (used to manage depression) antibiotics (used to manage bacterial infections) Ex. erythromycin, clarithromycin and telithromycin rifampicin (used in management of tuberculosis) saquinavir and ritonavir (used to manage HIV infections) medicines used for blood thinning (Ex. warfarin) medicines used to manage epilepsy (Ex. carbamazepine, phenytoin, and phenobarbital) medicines used to manage erectile dysfunction (Ex. tadalafil) B. Drug-Food Interactions: Avoid drinking grapefruit juice while receiving ASSURANS as it may increase the risk of side effects. Overdosage: ASSURANS will be given to you only by a doctor or nurse in a hospital, and so it is unlikely to receive an overdose. However, if you experience any unusual symptoms contact your doctor immediately. SYNOPSIS Drug : Sildenafil Pharmacological Category : Phosphodiesterase type 5 inhibitors Therapeutic Indication : Pulmonary Arterial Hypertension Dosage Forms : Tablet, Capsule, Oral Disintegrating Strips, Oral Jelly, Injection, Effervescent Tablet, Spray MORE INFORMATION Keep ASSURANS out of reach of children Store ASSURANS at room temperature